Medical Device & IVD Blog

Register medical devices in Chile through ISP, including classification, GICONA submission, fees, timelines, documentation, and the 2026 decree expansion.

Guide to the European Commission MDR and IVDR simplification proposal, including software Rule 11, certificate validity, sandboxes, fees, timelines, and manufacturer impact.

How FTC enforcement is reshaping medtech M&A in 2025-2026, including Edwards/JenaValve, GTCR/Surmodics, HSR changes, and state mini-HSR laws.

Guide to medical device valuation in 2025-2026, including EBITDA and revenue multiples, pre-revenue methods, deal structures, CVRs, earn-outs, and diligence.

Guide to medical device startup funding in 2026, including typical raise sizes by stage, VC evaluation criteria, active subsectors, investor landscape, and fundraising positioning.

Analysis of 2025-2026 medtech divestitures and spinoffs, including BD-Waters, J&J DePuy Synthes, Siemens Healthineers, Medtronic MiniMed, and why large players are breaking up.

Review the 2026 medtech IPO and SPAC outlook, including Medline, Medtronic MiniMed, digital health listings, SPAC activity, public market conditions, and the pipeline.

Register medical devices in Peru through DIGEMID, covering risk classification, VUCE submission, documentation, holder duties, fees, timelines, and market access strategy.

Analysis of private equity in medtech, including the Hologic take-private, buy-and-build platforms, CDMO acquisitions, Medline IPO exit, and dry powder deployment.

Analysis of surgical robotics M&A funding in 2025-2026, covering Intuitive, CMR Surgical, Medtronic Hugo, J&J OTTAVA, Distalmotion, VC, and PE consolidation.

Manage EU MDR Field Safety Corrective Actions, including FSCA triggers, 2/10/15-day reports, Field Safety Notices, EUDAMED, and FDA recall differences.

Use FMEA for medical device risk analysis, including DFMEA, PFMEA, UFMEA, ISO 14971 links, RPN scoring, step-by-step execution, and common errors.

Guide to complaint handling for medical devices under FDA QMSR, ISO 13485, and EU MDR, covering intake, reportability, CAPA links, records, and audits.

Six-country ASEAN matrix covering distributor licenses, QMS and warehouse requirements, vigilance setup, and where FDA or NMPA test reports may reduce retesting.

How to classify hand sanitizer, mouthwash, personal lubricants, and data recorders as medical devices or non-devices across FDA, EU MDR, Brazil ANVISA, and Mexico COFEPRIS.

2026 Brazil ANVISA device cost guide with government fees by class, BGMP audit costs, MDSAP carve-outs, ANATEL and INMETRO add-ons, and Brazilian Registration Holder retainers.

Learn how dual CE Mark and FDA 510(k)/PMA approval expands access across 25+ markets, speeds reliance registrations, and improves market-entry leverage.

Guide to FDA and EU regulation of drug-device combination products, covering OCP jurisdiction, RFDs, 21 CFR Part 4, EU MDR Article 117, CGMPs, and post-market duties.

Role-by-role playbook for the May 28, 2026 EUDAMED deadline, covering actor registration, UDI/device data, certificates, surveillance duties, and final readiness steps.

See where CE marking supports device approvals across 25+ markets, including full reliance, abridged review, evidence acceptance, and remaining local steps.